SNY Sanofi

By Preetika Rana 

The Philippines said Sanofi SA's troubled dengue vaccine may have caused the deaths of at least three children, months after the French drugmaker said its shot could worsen rather than prevent symptoms of the debilitating disease in some cases.

A government-ordered probe in the Philippines found a "causal association" between inoculation and the deaths of at least three out of the 14 children who are a focus of its investigation. "The children died due to dengue despite being vaccinated," the Department of Health said Friday. It added that two out of those three deaths "may be on account of vaccine failure."

The department cautioned that its results were preliminary. "Therefore, further testing of tissue samples and antibodies is also necessary in these cases to complete the investigation," it said.

Sanofi denied that its vaccine, the world's first against dengue, had caused any deaths. "There is currently no evidence directly linking the Dengvaxia vaccine to any of the 14 deaths," a spokesman responded in an email. "No deaths related to the vaccine have been reported to us."

The Philippines in December suspended a mass vaccination drive using Sanofi's Dengvaxia, after the Paris-based company late November said the vaccine wasn't suitable for people who had previously not been infected with dengue. For those people, "more cases of severe disease could occur" if they receive the vaccine and later contract the virus, Sanofi said. More than 800,000 children were inoculated in the Philippines.

Both houses of the Philippines Congress are separately probing the government's role in approving the mass drive.

Sanofi has stopped producing Dengvaxia and plans to take a $119 million charge in the fourth quarter. The company said it would reimburse the Philippines' $22.5 million of unused vaccine supplies.

The dengue virus infects 390 million people globally every year and kills tens of thousands, according to the World Health Organization. More than 200,000 people contracted dengue in the Philippines in 2016, the latest year for which data is available.

Write to Preetika Rana at preetika.rana@wsj.com

(END) Dow Jones Newswires

February 02, 2018 09:09 ET (14:09 GMT)

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